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Completed

NCT Number: NCT01454154

Glyburide (RP-1127) for Traumatic Brain Injury (TBI)

The primary objectives of this study are to assess whether participants with traumatic brain injury (TBI) administered glyburide begun within 10 hours of injury will show a decrease in magnetic resonance imaging (MRI)-defined edema and/or hemorrhage, compared to placebo and to assess the safety and tolerability of glyburide compared to placebo in participants with TBI. The secondary objectives include analyzing brain cell loss, computerized tomography (CT) scan /MRI abnormalities, reduction of mortality and or improvement of function or physiology, incidence of decompression craniectomy, incidence of neuroworsening, and to assess the steady state concentrations of glyburide in TBI participants.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California, San Diego, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented closed head TBI
  • Clearly defined time of injury no more than 10 hours before administration of study drug/placebo
  • GCS 4-14. The GCS will be obtained free of the effects of sedating and/or paralytic drug. Complicated mild must have GCS 13-14 and one or more of the following: Intraparenchymal clots or contusions in aggregate > 10cc; Midline shift > 5mm; IVH, SDH, EDH seen on more than one CT scan slice.
  • Age 18-75 years
  • Patients in whom a dedicated peripheral IV line can be placed for study drug administration
  • Written consent obtained from legally authorized representative (LAR)

Exclusion criteria

  • No documented TBI or time of impact not certain
  • Penetrating brain injury
  • Spinal column instability and/or spinal cord injury with neurodeficit
  • Concomitant severe non survivable injury
  • Pregnant, or a positive pregnancy test
  • Women who intend to breastfeed during Study Days 1-4.
  • Blood glucose <50mg/dL
  • Severe renal disorder from the patient's history (e.g. dialysis) or serum creatinine of > 2.5 mg/dL
  • Severe liver disease or total bilirubin >1.5 times upper limit of normal
  • INR>1.4
  • Systolic BP<90 mm Hg not responsive to fluid resuscitation
  • Blood alcohol > 250mg/dL
  • Inability to have MRI (pacemaker, non-MR compatible pressure monitor, etc.)
  • Hospitalization for brain injury, psychiatric or neurological disease within previous 3 years
  • Emergent or urgent surgical operation anticipated (in OR, bedside procedures excluded) that would prevent dosing with study drug within 8 hours of injury.
  • Known use of Coumadin (warfarin), Plavix (clopidogrel), Effient (prasugrel) or Pletal (cilostazol), heparin, low molecular weight heparin, heparinoids, or abciximab or similar antiplatelet agents in the previous 72 hours (Note that patients later found to have taken these medications will not be automatically excluded from the study.)
  • Use of sulfonylurea drugs within the prior 30 days
  • Treatment with another investigational drug within the prior 30 days
  • Allergy to sulfonylurea drugs
  • Known diagnosis of G6PD enzyme deficiency
  • PaO2 < 60 mm Hg on admission (for patients in whom blood gases are drawn per standard of care)
  • Non-English speaking legally authorized representative and subjects (University of Maryland only)
  • Prisoners or others who may be unable to make a truly voluntary and uncoerced decision whether or not to participate in the study
  • Any other clinical condition which in the opinion of the investigator makes the patient unsuitable for inclusion into the study

Treatment and study plan

Glyburide

Drug

Administered as specified in the Treatment Arm.

Other names: RP-1127, glibenclamide, glybenclamide

Placebo

Drug

Administered as specified in the Treatment Arm.

Primary outcomes

  1. Change from Baseline in Edema

    Time frame: Baseline, Day 3, Day 90, and Day 180

    To be assessed using Magnetic Resonance Imaging (MRI).

  2. Change from Baseline in Hemorrhage

    Time frame: Baseline, Day 3, Day 90, and Day 180

    To be assessed using MRI.

  3. Number of Participants with Adverse Events and Serious Adverse Events

    Time frame: Up to 180 Days

    An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. A serious adverse event is any AE that is fatal, life-threatening, requires or prolongs hospital stay, results in persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event

Secondary outcomes

  1. Change from Baseline in Brain Volume

    Time frame: Baseline, Day 3, Day 90, and Day 180

    To be assessed using MRI.

  2. Number of Participants with Abnormalities Associated with Brain Swelling

    Time frame: Baseline, Day 3, Day 90, and Day 180

    To be assessed using MRI and computed tomography (CT).

  3. Change from Baseline in Glasgow Coma Scale (GCS)

    Time frame: Baseline up to Day 7

    The GCS is scored between 3 and 15 (3 = the worst, and 15 = best). It is composed of three parameters : Best Eye Response (scored on a scale of 1-4), Best Verbal Response (scored on a scale of 1-5), Best Motor Response (scored on a scale of 1-6)

  4. Change from Baseline in Intracranial Pressure (ICP)

    Time frame: Baseline up to Day 7

  5. Change from Day 30 in Extended Glasgow Outcome Scale (GOS-E)

    Time frame: Day 30, Day 60, Day 90, and Day 180

    The GOS-E assesses status in patients with traumatic brain injury on an 8-point scale. The minimum score is 1 and the maximum score is 8. The rating scale is as follows: 1- Dead, 2- Vegetative State, 3- Low Severe Disability, 4- Upper Severe Disability, 5- Low Moderate Disability, 6- Upper Moderate Disability, 7- Low Good Recovery, and 8- Upper Good Recovery

  6. Number of Participants Requiring Decompression Craniectomy

    Time frame: Baseline up to Day 7

  7. Number of Participants Experiencing Neuroworsening

    Time frame: Baseline up to Day 7

  8. PK Parameter: Steady State Concentration of Glyburide

    Time frame: Baseline and 36 hours

  9. Number of All-Cause and Neurological Mortalities

    Time frame: Up to Day 180

Sponsors and collaborators

Lead sponsor

Remedy Pharmaceuticals, Inc.

Industry

Collaborators

  • INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
  • U.S. Army Medical Research and Development Command

Registry information

Official study title

A Randomized Clinical Trial of Glyburide (RP-1127) for TBI

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Oct 18, 2011
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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